Surgical suturing instrument and method of use

ABSTRACT

A device is disclosed for introducing a flexible elongated element through at least two portions of a subject. In an embodiment, the device includes a proximal end and a distal end, as well as an advancement unit for longitudinally advancing the flexible elongated element toward the distal end such that a proximal end of the elongated element may pass from the distal end of said device with sufficient force to pass through the portions of the subject. The device also includes a securing unit for variably adjusting a securing force applied by the flexible elongated element to secure together the portions of the subject.

REFERENCE TO PENDING PRIOR PATENT APPLICATION

[0001] This is a continuation-in-part of pending prior U.S. patentapplication Ser. No. 09/386,273, filed Aug. 3, 1999 by Gregory E.Sancoff et al. for SURGICAL SUTURING INSTRUMENT AND METHOD OF USE.

[0002] And this patent application claims benefit of pending prior U.S.Provisional Patent Application Serial No. 60/192,487, filed Mar. 27,2000 by Gregory E. Sancoff et al. for SURGICAL SUTURING INSTRUMENT ANDMETHOD OF USE (Attorney's Docket No. ONUX-15 PROV), which patentapplication is hereby incorporated herein by reference.

FIELD OF THE INVENTION

[0003] This invention relates to medical suturing instruments and moreparticularly to drive means in such instruments for advancing a suturestrand through tissue, and the like.

BACKGROUND OF THE INVENTION

[0004] Suturing instruments are typically used to draw together two ormore portions of a subject patient (e.g., tissue such as muscle or skin)or to attach an object to the patient (e.g., to attach a piece ofsurgical mesh to the abdominal wall of the patient during hernia repairsurgery).

[0005] Certain suturing instruments employ a needle that precedes alength of suture material through a subject.

[0006] For example, U.S. Pat. Nos. 3,470,875; 4,027,608; 4,747,358;5,308,353; 5,674,230; 5,690,653; 5,759,188; and No. 5,766,186 generallydisclose suturing instruments in which a needle, with trailing suturematerial, is passed through a subject.

[0007] U.S. Pat. Nos. 4,890,615; 4,935,027; 5,417,700; and No. 5,728,112generally disclose suturing instruments in which suture material ispassed through the end of a hollow needle after that needle has passedthrough a subject.

[0008] With all of the foregoing devices, a needle must be passedthrough the subject in order to deploy the suture. This is generallyundesirable, since the needle typically leaves a larger hole in thesubject than is necessary to accommodate only the suture material. Inthis respect it should be appreciated that it is generally desirable toalter each portion of the material being sutured as little as possible.

[0009] A suturing instrument has been devised which permits the suturematerial itself to pierce the subject without the use of a needle.However, this device does not permit sufficient flexibility with regardto the amount of tension that may be applied to the suture and tissue.

[0010] More particularly, U.S. Pat. No. 5,499,990 discloses a suturinginstrument in which a 0.25 mm stainless steel suturing wire is advancedto the distal end of a suturing instrument, whereupon the distal end ofthe suturing wire is caused to travel in a spiral direction so as toeffect stitches joining together two portions of a subject. After thespiral is formed, the beginning and end portions of the suture may bebent toward the tissue in order to inhibit retraction of the suture wireinto the tissue upon removal of the suturing instrument. The stainlesssteel wire is sufficiently firm to hold this locking set. In addition,after the spiral is formed, the radius of the deployed suture spiral maythen be decreased by advancing an outer tube over a portion of thedistal end of the instrument. Again, the stainless steel wire issufficiently firm to hold this reducing set.

[0011] Unfortunately, however, such a system does not permit sufficientflexibility in all situations with regard to the appropriate amount oftension to be applied to the subject, since the wire is relatively firm(i.e., firm enough to hold its sets). Such a system also does notprovide sufficient flexibility with regard to the appropriate type ofsuture stitch to be applied, since the device is specifically configuredto provide only a spiral suture stitch.

[0012] In contrast to the aforementioned limitations of the suturinginstrument of U.S. Pat. No. 5,499,990, it is desirable that a suturinginstrument approximate the portions of the material which is to bejoined in the correct physiological relationship, and to urge theportions together with an appropriate amount of force. If too much force(or tension) is applied to the suture material, then the subjectportions may become necrotic or the sutures may cut through the subject.If too little tension is applied to the suture material, then thehealing process may be impaired.

[0013] U.S. Pat. No. 4,453,661 discloses a surgical instrument forapplying staples. The staples are formed from the distal end of a lengthof wire. The distal end of the wire is passed through a subject, andthereafter contacts a die that causes the wire to bend, thereby formingthe staple. The wire is sufficiently firm to take the set imposed by thedie. The staple portion is then cut from the wire by a knife. Again,such a system suffers from the fact that it does not permit sufficientflexibility in all situations with regard to the appropriate tension tobe applied to the subject, since the attachment is made by a staplewhich has a predefined geometry and is formed with relatively firm wire.In addition, the system is limited as to the type of fastening which maybe applied, since the surgical instrument is limited to only applyingwire staples.

[0014] There is a need, therefore, for a new suturing device thatpermits minimally disruptive suturing and permits flexibility in theplacement, application, and tensioning of the suture material.

SUMMARY OF THE INVENTION

[0015] The invention provides a device for introducing a flexibleelongated element through a subject. In one embodiment, the deviceincludes a proximal end and a distal end, as well as an advancement unitfor longitudinally advancing the flexible elongated element toward thedistal end of the device such that a distal end of the flexibleelongated element may pass from the distal end of the device withsufficient force to pass through the subject. The device also includes asecuring unit for variably adjusting a securing force applied by theflexible elongated element so as to provide the desired securement tothe subject.

[0016] In further embodiments, the device includes a guide tube forguiding the flexible elongated element through the device, toward thedistal end of the device, as well as a rotation unit for rotating thedistal end of the device so as to cause the flexible elongated elementto wrap around itself, whereby to adjustably apply the securing force tothe flexible elongated element.

[0017] In still further embodiments, the device includes means fordirecting the flexible elongated element out of the distal end of thedevice in a manner causing the element to loop, or coil, through tissueto attach one tissue portion to another, or attach a portion of theelement to a selected tissue.

[0018] In yet further embodiments, the invention provides a tool forjoining a first layer of material to a second layer of material, saidtool comprising: a handle; an end effector mounted on said handle anddefining therein: a first channel for retaining a wire guide; a secondchannel extending from the first channel for supporting a suture wireextending from the wire guide; a passageway for retaining a cutter bar;and an end recess; said second channel being curved to impart a loopingconfiguration to portions of the suture wire passed therethrough; andsaid end recess having a curved surface at a bottom of said end recess,such that the end recess is adapted to receive the looped suture wireemerged from said second channel; a wire advancing actuator mounted onsaid handle for moving the suture wire through said second channel andthrough the material first and second layers; and a wire cuttingactuator mounted on said handle for moving the cutting bar into cuttingengagement with the suture wire.

[0019] And in still further embodiments, the invention provides a toolfor joining a first layer of material to a second layer of material,said tool comprising: a handle; an end effector mounted on said handleand comprising: a first fixed portion defining therein a first groovedefining a portion of a first channel for retaining a wire guide; asecond channel extending from the first channel for supporting a suturewire extending from the wire guide; a portion of a passageway forretaining a cutting bar; and wall structure defining a portion of an endrecess in a distal end of said end effector; and a second fixed portiondefining therein a first groove defining a remainder of the firstchannel; a second groove defining a remainder of said passageway; a wallportion defining a remainder of said second channel; and a sidewall fordefining a remainder of the end recess; said second channel being curvedto impart a looping configuration to portions of the suture wire passedtherethrough; the end recess being defined in part by a curved surfacein said end effector defining a bottom of the end recess, such that theend recess is adapted to receive the looped suture wire emerged fromsaid second channel; a wire advancing actuator mounted on said handlefor moving the suture wire through said second channel and through thematerial first and second layers; and a wire cutting actuator mounted onsaid handle for moving the cutting bar into cutting engagement with thesuture wire.

BRIEF DESCRIPTION OF THE DRAWINGS

[0020] These and other objects and features of the present inventionwill be more fully disclosed or rendered obvious by the followingdetailed description of the preferred embodiment of the invention, whichis to be considered together with the accompanying drawings wherein likenumbers refer to like parts, and further wherein:

[0021]FIG. 1 is a side view of a suturing instrument formed inaccordance with the present invention;

[0022]FIG. 2 is a partial side view, partially in section, of thesuturing instrument shown in FIG. 1;

[0023]FIG. 3 is a partial top view, partially in section, of thesuturing instrument shown in FIG. 1;

[0024]FIG. 4 is a schematic partial side view showing some of theinternal components of the suturing instrument shown in FIG. 1;

[0025]FIG. 4A is a perspective view of a drive barrel assemblyincorporated in the suturing instrument shown in FIG. 1;

[0026]FIG. 5 is a perspective view of a wire guide support unitincorporated in the suturing instrument shown in FIG. 1;

[0027]FIG. 6 is a perspective view of the suturing instrument's wiresupply cartridge, which includes the wire guide support unit shown inFIG. 5;

[0028]FIG. 7 is a perspective view, partially in section, of the wiresupply cartridge shown in FIG. 6;

[0029]FIG. 8 is a perspective rear view of the drive barrel assemblyincorporated in the suturing instrument shown in FIG. 1, with the drivebarrel assembly's release lever being shown in its closed position;

[0030]FIG. 9 is a perspective view of the proximal (i.e., rear) end ofthe drive barrel assembly shown in

[0031]FIG. 8, with the release lever being shown in its open position;

[0032]FIG. 10 is a perspective view of the proximal (i.e., rear) end ofthe same drive barrel assembly, with the release lever being shown inits closed position, and with the wire guide and wire guide support unitbeing advanced relative to the drive barrel assembly (but with theremainder of the wire supply cartridge being removed from view);

[0033]FIG. 11 is a schematic view taken along the line 11-11 of FIG. 4;

[0034]FIG. 12 is a side view of a shaft and an end effector portion ofthe suturing instrument shown in FIG. 1;

[0035]FIG. 13 is a side view of the end effector portion of the suturinginstrument shown in FIG. 1;

[0036]FIG. 14 is a side view, partially in section, of the end effectorportion shown in FIG. 13, with the end effector portion being shown withits cutting bar in its forward (i.e., non-cutting) position;

[0037]FIG. 15 is a side view, partially in section, of the end effectorportion shown in FIG. 14, but with the end effector portion being shownwith its cutting bar in its retracted (i.e., cutting) position;

[0038]FIG. 16 is a perspective view of the end effector portion of thesuturing instrument shown in FIG. 1;

[0039] FIGS. 17A-17J show various steps in a suturing operationconducted with the suturing instrument shown in FIG. 1;

[0040]FIG. 18 is a sectional view showing one possible construction forthe suturing instrument's fixed jaw portion and its associated cuttingbar;

[0041]FIG. 19 is a side view showing a piece of wire cut with theapparatus shown in FIG. 18;

[0042]FIG. 20 is a sectional view showing another possible fixedconstruction for the suturing instrument's fixed jaw portion and itsassociated cutting bar;

[0043]FIG. 21 is a side view showing a piece of wire cut with theapparatus shown in FIG. 20;

[0044]FIG. 22 is a side view, partially in section, of the end effectorportion of the device, wherein the end effector portion includes apiezoelectric element to aid in wire penetration;

[0045]FIG. 23A is a schematic diagram of the device's fixed jaw portion,illustrating how the suture wire may sometimes curve as it exits thefixed jaw portion;

[0046]FIG. 23B is a schematic diagram of a modified form of the device'sfixed jaw portion, illustrating how the profile of the device can bemodified so as to counteract the aforementioned wire curvature;

[0047]FIG. 23C is a schematic diagram of a modified form of the device'smovable jaw portion, illustrating how the mouth of the movable jawportion's opening may be enlarged so as to facilitate suture capture;

[0048]FIG. 24 is a schematic diagram of a modified form of the device,wherein one or more legs have been provided to help stabilize the tissueduring suturing;

[0049]FIG. 25 is a schematic diagram of another modified form of thedevice, wherein a second set of jaws have been added to the device tohelp stabilize the tissue during suturing;

[0050]FIG. 26 is a perspective view of a portion of an alternative endeffector portion of the instrument;

[0051]FIG. 27 is a perspective view of a further portion of thealternative end effector portion;

[0052]FIG. 28 is a perspective view of the alternative end effector,including the portions of FIGS. 26 and 27;

[0053]FIG. 29 is a diagrammatic illustration of the alternative endeffector in operation;

[0054] FIGS. 30-33 are diagrammatic illustrations of alternative modesof suturing accomplished with the alternative end effector;

[0055]FIG. 34 is a diagrammatic side elevational view, broken away,showing an alternative use of a looped suture wire produced by thealternative effector portion of the instrument;

[0056]FIG. 35 is a perspective view of an end portion of anotheralternative embodiment of end effector; and

[0057]FIG. 36 is a perspective view of another alternative embodiment ofend effector portion of the instrument.

[0058]FIG. 37 is a side elevational view of still another alternativeembodiment of instrument;

[0059]FIG. 38 is a perspective view of an alternative configuration ofend effector;

[0060] FIGS. 39-41 are perspective views of still another alternativeembodiment of end effector;

[0061]FIGS. 42a-42 c are diagrammatic illustrations of suturing by useof an alternative end effector; and

[0062]FIG. 43 is an exploded view of still another alternativeembodiment of end effector.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT Overview

[0063] Looking first at FIG. 1, there is shown a suturing instrument 10which comprises a preferred embodiment of the present invention.Suturing instrument 10 includes a housing 12, a handle 14, a shaft 16and an end effector 18. Suturing instrument 10 also includes a wireadvance button 20, a jaw closing actuator 22, a wire cutting actuator24, a left-thumb-actuated rotation button 26, and a right-thumb-actuatedrotation button 28 (FIG. 3). Suturing instrument 10 also includes a wiresupply cartridge 30, as well as a shaft retaining nut 32. Shaftretaining nut 32 allows shaft 16 to be dismounted from the remainder ofthe device for cleaning purposes.

[0064] As will be discussed in further detail below, generally duringuse, suture wire (comprising wire formed of metal or any other suitablematerial having the required flexibility and stiffness) is drawn from awinding in wire supply cartridge 30 and is pushed through housing 12 andshaft 16 to end effector 18, which includes a pair of opposing jawportions. The jaw portions may be brought together around the materialwhich is to be sutured by actuating jaw closing actuator 22 when the jawportions are positioned at an appropriate surgical location. The suturewire is driven through housing 12 and shaft 16 to end effector 18 byactuating wire advance button 20. The suture wire is driven from one jawportion to the other jaw portion with sufficient force to penetrate thetissue placed between the jaw portions, and the suture wire is permittedto pass through the second jaw portion. The jaw portions are thenpermitted to separate and move away from the tissue, leaving the suturewire extending from the subject tissue to each of the two jaw portions.Shaft 16 and end effector 18 (together with wire supply cartridge 30)may then be rotated with respect to housing 12 and handle 14 byactuating either left-thumb-actuated rotation button 26 orright-thumb-actuated rotation button 28. This causes the portions of thesuture wire that extend from the tissue to be twisted about one anotherso as to form a closed loop extending through the tissue. It will beappreciated that the size of this closed loop may be adjustably reducedby increasing the degree of twisting in the wire. The twisted loop ofsuture wire may then be cut off, at end effector 18, from the remainingportion of the suture wire that extends back through the suturinginstrument. Such cutting may be effected by actuating wire cuttingactuator 24.

[0065] As will be discussed in further detail below, wire supplycartridge 30 may be supplied separately from suturing instrument 10,with the wire supply cartridge 30 being loaded into suturing instrument10 prior to commencing a suturing operation. As will also be discussedin further detail below, wire supply cartridge 30 may be disposable,such that the cartridge may be discarded after all of its wire has beenused up.

Construction Details

[0066] As shown in FIGS. 2 and 4, handle 14 provides a cavity that mayreceive batteries 34. In other embodiments, the unit may be poweredremotely via a power transmission cord or any other source of suitablepower.

[0067] Batteries 34 supply a ground (or negative) potential to a groundconnector post 36 (FIG. 2), which in turn communicates with a rotaryground communicator 38. Rotary ground communicator 38 permits electricalcontact to be maintained with ground connector post 36 when rotaryground communicator 38 is rotated with respect to ground connector post36, as occurs when shaft 16 and end effector 18 are rotated so as totwist closed suture wire extending through the tissue.

[0068] Batteries 34 supply a positive potential to wire advance button20, and to a first connector post 40, which in turn communicates with afirst rotary electrical communicator 42. First rotary electricalcommunicator 42 permits electrical contact to be maintained with firstconnector post 40 when first rotary electrical communicator 42 isrotated with respect to first connector post 40. The positive potentialfrom batteries 34 is also supplied (in parallel) to each thumb-activatedrotation button 26, 28 (FIG. 3), and to a second connector post 44 (FIG.2), which in turn communicates with a second rotary electricalcommunicator 46. Again, second rotary electrical communicator 46 permitselectrical contact to be maintained with second connector post 44 whensecond rotary electrical communicator 46 is rotated with respect tosecond connector post 44. Each of the connector posts 36, 40 and 44 maybe spring-biased so as to remain in contact with its respective rotarycommunicator. In view of the foregoing construction, the positivepotentials may be switched on by depressing the respective actuatorbutton 20, 26, 28. Handle 14 also includes a cap 48 which may be removedso as to permit insertion of batteries 34.

[0069] First rotary electrical communicator 42 is in electricalcommunication with a wire advance motor 50 shown in FIGS. 2 and 4. Theoutput shaft of wire advance motor 50 is coupled to a miter drive gear52, which is in turn coupled to a miter follower gear 54. Miter followergear 54 is coupled to a drive wheel 56 which contacts a suture wire 58,as will be described in further detail below with reference to FIGS.5-10.

[0070] Second rotary electrical communicator 46 is in electricalcommunication with a shaft rotation motor 60 (FIGS. 3 and 4), the outputof which is coupled to a pinion gear 62 (FIGS. 4, 4A and 11) thatrotates along an internal gear 64 (FIGS. 4 and 11). As shown in FIG. 3,left-thumb-actuated rotation button 26 and right-thumb-activatedrotation button 28 may be provided to permit the user to use the thumbof either their left hand or their right hand, respectively, so as toactuate shaft rotation motor 60. In this respect it will be appreciatedthat, inasmuch as left-thumb-actuated rotation button 26 andright-thumb-actuated rotation button 28 are wired in parallel, shaftrotation motor 60 will rotate in the same direction regardless of whichbutton (i.e., button 26 or button 28) may be actuated.

[0071] Jaw closing actuator 22 (FIGS. 2 and 4) is coupled to a jawlinkage coupler 66, which in turn contacts a jaw linkage 68 (FIGS. 2 and14). When jaw closing actuator 22 is pulled toward handle 14 (FIG. 2),jaw closing actuator 22 pivots on its pivot pin 67 (FIG. 4) so as todrive jaw linkage coupler 66 distally, against the force of biasingspring 69, and so as to cause the jaw linkage 68 to move forward towardthe distal end of suturing instrument 10. This action will in turn causea movable jaw portion 98 to close on a fixed jaw portion 96 (FIG. 17A),as will hereinafter be discussed in further detail. When jaw closingactuator 22 is subsequently released, biasing spring 69 (FIG. 4) drivesjaw linkage coupler 66 proximally, so as to cause jaw linkage 68 to moveproximally. This action will cause movable jaw portion 98 to openrelative to fixed jaw portion 96 (FIG. 14), as will hereinafter bediscussed in further detail. The action of jaw linkage 68 at the distalend of the device is discussed further below with reference to FIGS. 13and 14.

[0072] Wire cutting actuator 24 is coupled to a wire cutting linkagecoupler 70 (FIGS. 2 and 4), which in turn contacts a wire cuttinglinkage 72 (FIGS. 2, 14 and 15). When wire cutting actuator 24 is pulledtoward handle 14 (FIG. 2), wire cutting actuator 24 pivots on its pivotpin 73 (FIG. 4) so as to drive wire cutting linkage coupler 70proximally, against the force of biasing spring 69, and so as to causewire cutting linkage 72 to move proximally, away from the distal end ofsuturing instrument 10. This action will in turn cause cutting bar 104(FIG. 14) to move proximally (FIG. 15) so as to effect wire cutting, aswill hereinafter be discussed in further detail. When wire cuttingactuator 24 is subsequently released, biasing spring 69 drives wirecutting linkage coupler 70 distally, so as to cause wire cutting linkage72 to move distally. This action causes a cutting bar 104 to movedistally, so as to assume the position shown in FIG. 14. Wire cuttinglinkage 72 moves adjacent to, and independent of, jaw linkage 68discussed above. The action of wire cutting linkage 72 at the distal endof the device is discussed further below with reference to FIGS. 14 and15.

[0073] The wire supply cartridge 30 shown in FIG. 1 includes a wireguide support unit 74, as shown in FIGS. 5-7. A supply coil of suturewire 58 (comprising wire formed of metal or any other suitable materialhaving the required flexibility and stiffness) may be supplied in thebase of cartridge 30 and is fed into the support unit 74 as shown inFIG. 7. A wire guide 76 surrounds suture wire 58, from support unit 74to the distal end of suturing instrument 10, adjacent to end effector 18(FIGS. 5-7, 14 and 15). Wire guide 76 ensures that suture wire 58 doesnot bend or buckle as the suture wire is pushed through housing 12 andshaft 16. More particularly, wire guide 76 preferably forms asufficiently close sliding fit with suture wire 58 such that suture wire58 cannot bend or buckle as the suture wire is advanced through suturinginstrument 10. At the same time, wire guide 76 is also formed so as topresent a minimum of friction to suture wire 58 as the suture wire isadvanced through the instrument. The foregoing characteristics areimportant, inasmuch as suture wire 58 is extremely thin and flexible andhighly susceptible to bending or buckling in the absence of some sort oflateral support.

[0074] By way of example but not limitation, where suture wire 58 isformed out of stainless steel and has a diameter of 0.005 inch, wireguide 76 might have an inside diameter of 0.008 inch and an outsidediameter of 0.016 inch. In addition, wire guide 76 is preferably formedout of polytetrafluoroethylene (PTFE) or some other relativelylubricious material. Alternatively, the interior of wire guide 76 may becoated with a lubricant so as to facilitate closely-supported,low-friction passage of the suture wire through the wire guide.

[0075] Further by way of example but not limitation, in one preferredform of the invention, suture wire 58 may comprise 316 LVM stainlesssteel having a tensile strength of 170 kpsi.

[0076] Although wire guide 76 extends through support unit 74 (FIG. 7),wire guide 76 has two openings 78 (one on either side of wire guide 76,only one of which is shown in FIG. 5) in the center of support unit 74.Openings 78 expose a portion of suture wire 58 so that wire drive wheel56 (FIG. 8) may contact suture wire 58 and urge the suture wire forwardtoward the distal end of suturing instrument 10, as will be discussed indetail below with reference to FIGS. 8-10.

[0077] As shown in FIGS. 2, 3, 4A and 8, housing 12 receives a drivebarrel assembly 80 that contains the aforementioned motors 50 and 60,and provides a distally-extending barrel shaft 81 (FIGS. 4A and 8), onthe outside of which are located the rotary communicators 38, 42 and 46.A recess 82 (FIG. 4A) is provided on the distal end of barrel shaft 81for receiving a coupling pin 84 (FIGS. 2 and 4) which is located on theproximal end of shaft 16, such that rotation of drive barrel assembly 80causes rotation of coupling pin 84 and hence shaft 16. Drive barrelassembly 80 is rotationally held within housing 12 by bearings 86, asshown in FIGS. 2 and 3.

[0078] Looking next at FIGS. 7-10, wire supply cartridge 30 may beattached to drive barrel assembly 80 by rotating a release lever 87 awayfrom the center of drive barrel assembly 80 (FIGS. 8 and 9), so as tomove a carriage 88 relative to drive barrel assembly 80. Mostparticularly, release lever 87 rides on a pin 90, and rotation ofrelease lever 87 from the position shown in FIG. 8 to the position shownin FIG. 9 draws carriage 88, as well as a wire follower wheel 92, awayfrom the center of drive barrel assembly 80. Once wire follower wheel 92is separated from wire drive wheel 56 by a sufficient distance to exposethe drive barrel assembly's central passageway 93 (FIG. 9), wire guide76 (overlying suture wire 58) may be inserted into passageway 93 (FIG.10), and wire guide support unit 74 (FIGS. 6, 7 and 10) may be insertedbetween wheels 56 and 92 (FIG. 10), such that wheels 56 and 92 contacteither side of suture wire 58 through openings 78 formed in either sideof wire guide 76. A biasing spring 94 (FIGS. 8-10) is provided oncarriage 88 to urge wire follower wheel 92 into close contact withsuture wire 58. In other embodiments, wire follower wheel 92 may also bedriven indirectly by wire drive wheel 56 in order to provide additionalforces to move suture wire 58 distally (i.e., forward, toward the tool'send effector 18).

[0079] Pinion gear 62 (FIGS. 4, 4A and 11) extends distally from drivebarrel assembly 80 and engages the housing's internal gear 64, as shownin FIGS. 4 and 11. As a result of this construction, when shaft rotationmotor 60 is actuated, pinion gear 62 rotates around internal gear 64,bringing with it the entire drive barrel assembly 80. This in turncauses shaft 16 to rotate, since shaft 16 is coupled to drive barrelassembly 80. More particularly, the rotation of drive barrel assembly 80is transferred to shaft 16 through the shaft's coupling pin 84 (FIGS. 2,4 and 12), which is seated in recess 82 (FIG. 8) of drive barrelassembly 80.

[0080] End effector 18 (FIGS. 1 and 13-16) includes the fixed jawportion 96 and the movable jaw portion 98. Movable jaw portion 98 iscoupled to the aforementioned jaw linkage 68 (FIG. 14) via a jaw linkagepin 100, such that when jaw linkage 68 is moved distally (i.e., bypulling jaw closing actuator 22 toward handle 14), jaw portion 98 isrotated about a pivot pin 102 (FIG. 13) and closes onto fixed jawportion 96. Conversely, when jaw linkage 68 is moved proximally (i.e.,by the power of biasing spring 69 acting on jaw linkage coupler 66 andhence jaw linkage 68), movable jaw portion 98 will open away from fixedjaw portion 96. It will be appreciated that the force of biasing spring69 will normally keep movable jaw portion 98 open relative to fixed jawportion 98 (FIGS. 1, 13 and 14), unless and until jaw closing actuator22 is activated so as to overcome the bias of spring 69.

[0081] Wire cutting linkage 72 (FIGS. 2, 3, 14 and 15) is coupled tocutting bar 104 (FIGS. 14 and 15) that includes a small opening 106through which suture wire 58 may pass, as will hereinafter be discussedin further detail. Preferably cutting bar 104 is slidably received in apassageway 107 (FIGS. 14, 15, 16 and 17H) formed in fixed jaw portion96. In one position (FIG. 14), cutting bar 104 is positioned in fixedjaw portion 96 such that the cutting bar's opening 106 is aligned with achannel 108 formed in fixed jaw portion 96, whereby suture wire may bepassed from the distal end of wire guide 76, through channel 108 formedin fixed jaw portion 96 (where it undergoes an approximately 90 degreechange of direction), through opening 106 in cutting bar 104, through achannel extension 108A formed in fixed jaw portion 96, and across tomovable jaw portion 98, as will hereinafter be discussed in furtherdetail. However, when wire cutting linkage 72 is moved proximally bypulling wire cutting actuator 24 toward handle 14, cutting bar 104 isalso moved proximally (FIG. 15) so as to cut any suture wire extendingfrom channel 108 (in fixed portion 96) into opening 106 (in cutting bar104). In this respect it will be appreciated that it is desirable toform channel extension 108A with a length greater than channel 108 (seeFIGS. 14 and 15) so as to prevent the suture wire from being cut in twoplaces (i.e., at channel 108 and again at channel extension 108A) whencutting bar 104 is moved proximally by pulling on wire cutting actuator24. At the same time, however, it should also be appreciated that thefixed jaw portion's channel 108 and channel extension 108A, and thecutting bar's opening 106, are all sized, relative to suture wire 58, soas to provide as much support as possible to the suture wire as itpasses through, and out of, fixed jaw portion 96.

[0082] It will be appreciated that the force of biasing spring 69 willnormally keep cutting bar 104 in its distal position (i.e., with thecutting bar's opening 106 aligned with the fixed jaw portion's channel108), unless and until wire cutting actuator 24 is activated so as toovercome the bias of spring 69.

[0083] In view of the foregoing construction, it will be seen that: (1)release lever 87 (FIGS. 8-10) may be activated so as to move wirefollower wheel 92 away from, and toward, wire drive wheel 56 so as topermit a full wire supply cartridge 30 (FIGS. 1 and 5-7) to be loadedinto suturing instrument 10; (2) activating jaw closing actuator 22 willcause movable jaw portion 98 to close on fixed jaw portion 96; (3)activating wire advance button 20 will cause wire drive wheel 56 toadvance suture wire 58 through housing 12 and shaft 16; (4) activatingrotation button 26 and/or rotation button 28 will cause shaft 16 torotate relative to housing 12; and (5) activating wire cutting actuator24 will cause cutting bar 104 to move proximally so as to sever anysuture wire extending from fixed jaw portion 96.

Operation

[0084] Suturing instrument 10 may be used to apply wire suture 58 to asubject so as to effect a desired suturing operation.

[0085] By way of example but not limitation, and looking now at FIGS.17A-17J, suturing instrument 10 may be used to suture together twoportions 110, 112 of a subject which is to be sutured. In a typicalcase, portions 110, 112 might comprise two sections of severed tissuewhich need to be reattached to one another, or two pieces of previouslyunattached tissue which need to be attached to one another. However, oneor the other of the portions 110, 112 might also comprise artificialmesh or some other object being attached to tissue, etc. In addition, ina typical case, portions 110, 112 might be located relatively deepwithin a patient, and might be accessed during a so-called “minimallyinvasive”, or a so-called “closed surgery”, procedure; however, in othercircumstances, portions 110, 112 might be accessed during aconventional, or so-called “open surgery”, procedure. This latersituation might include procedures done at the outer surface of thepatient's body, i.e., where portions 110, 112 comprise surface subjects.

[0086] In any case, suturing instrument 10 is initially prepared for useby installing batteries 34 into handle 14, if batteries 34 are notalready installed, and by installing wire supply cartridge 30 into thesuturing instrument, if a cartridge 30 is not yet installed. As notedabove, wire supply cartridge 30 is installed in suturing instrument 10by (1) moving the drive barrel assembly's release lever 87 to its openposition (FIG. 9), so as to move wire follower wheel 92 away from wiredrive wheel 56 and thereby expose the barrel assembly's centralpassageway 93; (2) passing the distal end of the cartridge (i.e., thedistal end of wire guide 76) through drive barrel assembly 80 and shaft16 until the distal end of wire guide 76 is in communication with thechannel 108 formed in fixed jaw portion 96 (FIG. 14), at which point thecartridge's wire guide support unit 74 will be positioned intermediatewire drive wheel 56 and wire follower wheel 92 (FIG. 2); and (3) movingthe drive barrel assembly's release lever 87 back to its closed position(FIG. 8), so as to cause wire drive wheel 56 and wire follower wheel 92to extend through the wire guide's openings 78 and engage suture wire58.

[0087] At this point suturing instrument 10 will be ready for use, withits movable jaw portion 98 being opened away from its fixed jaw portion96, and with its cutting bar 104 being in its forward (FIG. 14)position.

[0088] Next, suturing instrument 10 has its movable jaw portion 98 movedinto engagement with its fixed jaw portion 96 (i.e., the jaws 96, 98 areplaced in their “closed” position) by pulling jaw closing actuator 22toward handle 14, and then the distal end of suturing instrument 10 ismoved adjacent to subject portions 110, 112 (FIG. 17A).

[0089] In the case of a so-called closed surgical procedure, suchpositioning will generally involve moving the distal end of the suturinginstrument through a cannula and into an interior body cavity; however,it is also envisioned that one might move the distal end of the suturinginstrument directly into an otherwise-accessible body cavity, e.g.,directly into the colon or esophagus, etc. In the case of a so-calledopen surgical procedure, such positioning might involve positioning thedistal end of the suturing instrument adjacent to more readilyaccessible subject portions 110, 112.

[0090] In any case, once the distal end of suturing instrument 10 hasbeen placed adjacent to subject portions 110, 112, jaw closing actuator22 is released, such that biasing spring 69 (FIG. 4) will cause movablejaw portion 98 to open away from fixed jaw portion 96 (FIG. 17B). Thenthe distal end of suturing instrument 10 is moved so that its jaws 96,98 straddle subject portions 110, 112, and then jaw closing actuator 22is actuated again, by pulling jaw closing actuator 22 toward handle 14,so as to close movable jaw portion 98 against fixed jaw portion 96,whereby to capture subject portions 110, 112 (FIG. 17C).

[0091] Next, wire advance button 20 is activated so as to cause suturewire 58 to be driven forward, out of the distal end of wire guide 76,through the fixed jaw portion's channel 108, through opening 106 incutting bar 104, through the fixed jaw portion's channel extension 108A,through subject portions 110, 112, and finally through an opening 113(FIGS. 14, 15 and 17C) formed in movable jaw portion 98. Suture wire 58is preferably advanced so that a length 58A of wire 58 extendsapproximately 1 centimeter out of the bottom end of movable jaw portion98 (FIG. 17C). In this respect it will be appreciated that, as suturewire 58 leaves fixed jaw portion 96 and engages subject portions 110,112, the fixed jaw portion's channel 108, the cutting bar's opening 106and the fixed jaw portion's channel extension 108A will support the thinsuture wire so as to enable the suture wire to penetrate subjectportions 110, 112.

[0092] Once this has been done, jaw closing actuator 22 is released soas to permit movable jaw portion 98 to return to its “open” positionrelative to fixed jaw portion 96, and then wire advance button 20 isused to pay out additional suture wire 58 as the distal end of suturinginstrument 10 is stepped back (e.g., by about a centimeter or so) fromsubject portions 110, 112 (FIG. 17D).

[0093] Then jaw closing actuator 22 is used to move jaw portion 98 backinto engagement with fixed jaw portion 96 once more (FIG. 17E).

[0094] Next, left-thumb-actuated rotation button 26, orright-thumb-actuated rotation button 28, is used to rotate shaft 16 andhence end effector 18. This causes suture wire 58 to twist on itself,initially creating a relatively large loop 116 (FIG. 17F) of suture wire58 extending from subject portions 110, 112 toward suturing instrument10. However, as rotation button 26 and/or rotation button 28 is used torotate shaft 16 (and hence end effector 18) more and more, the loop 116of suture material will progressively close down (FIG. 17G) so as toform a tight binder for subject portions 110, 112. In this respect itwill be appreciated that the longer the period of time that end effector18 is rotated, the greater the amount of twisting of suture wire 58, andthe greater the force holding subject portions 110, 112. In this respectit will also be appreciated that suture wire 58 is preferably carefullyselected with respect to its flexibility relative to the strength ofsubject portions 110, 112. In particular, suture wire 58 is chosen so asto have a flexibility such that the suture wire will twist, and loop 116will close down, before subject portions 110, 112 will undergosubstantial deformation and/or tearing. By way of example but notlimitation, in practice, it has been found that 0.005 inch diameterstainless steel wire can be used with most types of mammalian tissuesuch that the suture wire can be twisted closed without causingsubstantial deformation and/or tearing of the tissue.

[0095] Once suture wire 58 has been tightened to the desired degree,rotation of shaft 16 and end effector 18 is stopped, i.e., by releasingbutton 26 or button 28. Then wire cutting actuator 24 is depressed(e.g., it is pulled back toward handle 14) so as to pull cutting bar 104proximally and thereby sever the suture wire 58 as the suture wireemerges from the fixed jaw portion's channel 108 and enters the cuttingbar's opening 106. This action separates the deployed suture wireextending through subject portions 110, 112 from the suture wireremaining in wire supply cartridge 30, wire guide 76 and the fixed jawportion's channel 108.

[0096] Then wire cutting actuator 24 is released, allowing biasingspring 69 to return cutting bar 104 to its distal position, and then jawclosing actuator 22 is released, allowing movable jaw portion 98 to moveaway from fixed jaw portion 96. Suturing instrument 10 may then beremoved from subject portions 110, 112, which action will pull wirelength 58A from movable jaw portion 98 (FIG. 17I).

[0097] The deployed suture wire 58 may then be pressed down flat againstsubject portions 110, 112, or rounded into a ball, or otherwise operatedupon, so as to reduce the profile of, or reduce the tendency to snag on,the deployed suture wire (FIG. 17J).

[0098] It will be appreciated that suturing instrument 10 will haveapplication in a broad range of different suturing operations. Moreparticularly, it will be appreciated that suturing instrument 10 willhave application in both “open” and “closed” surgical procedures, withthe former including, but not limited to, large entry procedures,relatively shallow procedures, and surface procedures; and with thelatter including, but not limited to, surgical procedures where accessis gained to an interior structure through the use of a cannula, andsurgical procedures where access is gained directly to an internal bodycavity without the use of a cannula, e.g., such as a procedure conductedwithin the colon or the esophagus.

[0099] It will also be appreciated that suturing instrument 10 will haveapplication where two portions of tissue must be attached to one another(e.g., where two severed pieces of tissue must be re-attached to oneanother, or where two separate pieces of tissue must be attached to oneanother, or where two sections of a single piece of tissue must beapproximated to one another), and where an object must be attached tothe patient (e.g., where surgical mesh must be attached to the patient'sabdominal wall during hernia repair surgery, etc.).

[0100] Among other things, it is believed that suturing instrument 10will have particular application in the areas of general laparoscopicsurgery, general thoracic surgery, cardiac surgery, general intestinalsurgery, vascular surgery, skin surgery and plastic surgery.

[0101] Looking next at FIGS. 18 and 19, it will be seen that where thefixed jaw portion's channel 108 is disposed so as to be substantiallyaligned with the center of cutting bar 104 (FIG. 18), suture wire 58will be cut with a relatively flat leading end 58B (FIG. 19). However,it has sometimes been found helpful to provide suture wire 58 with arelatively sharp leading point. Such a leading point can help open thesubject for the following portion of the suture wire. In addition, sucha leading point can help the suture wire penetrate the subject with asubstantially straight path, so that the suture wire will reliably enterthe movable jaw portion's opening 113. To this end, it has been foundthat moving the fixed jaw portion's channel 108 off-center relative tocutting bar 104 (FIG. 20) will cause the leading end 58B of suture wire58 to be formed with a relatively sharp tip 58C (FIG. 21).

[0102] It is also possible to use suturing instrument 10 to ligate asubject rather than to pass a suture through the subject. For example,suturing instrument 10 might be used to ligate a blood vessel withsuture wire 58. In this case, suturing instrument 10 is deployed so thatsuture wire 58 will pass around the far side of the subject, rather thanthrough the subject as in the case of the suturing operation of the typedescribed above.

[0103] By way of example but not limitation, in a typical ligatingoperation, movable jaw portion 98 is first opened relative to fixed jawportion 96. Then suturing instrument 10 is positioned about the subjectso that when movable jaw portion 98 is thereafter closed toward fixedjaw portion 96, the fixed jaw portion's channel 108 and the movable jawportion's opening 113 will both lie on the far side of the subject. Themovable jaw portion 98 is then closed against the fixed jaw portion 96,and suture wire 58 is passed from fixed jaw portion 96 to movable jawportion 98, i.e., around the far side of the subject. The movable jawportion 98 is then opened, and suture wire 58 is layed out as theinstrument is stepped back from the subject. Then the movable jawportion 98 is again closed against the fixed jaw portion 96. The shaftof the instrument is then rotated so as to form, and then close down,the ligating loop. Then cutting bar 104 is activated so as to cut theligating loop from the remainder of the suture wire still in the tool,the movable jaw member 98 is opened, and the instrument is withdrawnfrom the surgical site. The deployed suture wire 58 may then be presseddown flat against the subject, or rounded into a ball, or otherwiseoperated upon, so as to reduce the profile of, or reduce the tendency tosnag on, the deployed suture wire. As will be appreciated by a personskilled in the art, where instrument 10 is to be used for ligatingpurposes, fixed jaw portion 96 and movable jaw portion 98 might beformed with a greater longitudinal length so as to facilitate passingthe suture wire around the far side of the subject. Furthermore, movablejaw member 98 might be formed with a recess, intermediate its jawlinkage pin 100 (FIG. 15) and its opening 113, for accommodating thesubject, whereby to prevent compressing the subject when movable jawmember 98 is moved into engagement with fixed jaw member 96.

[0104] Suture wire 58 may comprise a wire formed out of a metal or anyother suitable material having the required flexibility and stiffness.By way of example but not limitation, suture wire 58 may comprisestainless steel, titanium, tantalum, etc.

[0105] If desired, suture wire 58 may also be coated with various activeagents. For example, suture wire 58 may be coated with ananti-inflammatory agent, or an anti-coagulant agent, or an antibiotic,or a radioactive agent, etc.

[0106] Looking next at FIG. 22, it is also possible to impart ultrasoundenergy to the wire in order to make tissue penetration easier. Moreparticularly, because of the small cross-sectional area of the wire andthe propensity for the wire to buckle when axially loaded, it isbeneficial to be able to advance the wire into tissue with a minimum ofload. This can be achieved by appropriately applying ultrasound energyto the wire.

[0107] A piezoelectric element 200 is placed at the outside radius ofthe wire guide path 108 at the right angle bend in the fixed jaw portion96 just before where the wire enters the tissue. The piezoelectricelement 200 vibrates at a position along this bend such that it supportsthe wire in completing the turn but also imparts a component ofdisplacement in the direction of the tissue. Displacement of this kindat ultrasonic frequencies, in addition to the existing wire drivingmeans, would cause the tip of the wire to penetrate the tissue usingless force. In addition to reducing the tendency for outright wirebuckling, lowering the wire loads will also allow the wire penetrationto proceed in a straighter path.

[0108] Looking next at FIG. 23A, it will be seen that, in somecircumstances, the suture wire 58 may exit fixed jaw portion 96 with acurvature, due to the fact that suture wire 58 follows a curved channel108 in fixed jaw portion 96. In some cases this curvature in the suturewire 58 may be quite modest, so that it may be effectively ignored.However, in other circumstances, this curvature might be large enough tocause the suture wire advancing out of fixed jaw portion 96 to miss thetarget opening 113 in movable jaw portion 98. In this case the curvaturein suture wire 58 can present a significant problem. However, andlooking now at FIG. 23B, it has been found that the profile of thecutting bar's opening 106 may be modified so as to provide a deflectingdie which will counteract undesirable curvature in the suture wire andreturn the suture wire to a straight path as the suture wire exits fixedjaw portion 96. Alternatively, the profile of the fixed jaw portion'schannel 108 may be modified, adjacent to cutting bar 104, so as toprovide a similar deflecting die which will counteract undesirablecurvature in the suture wire and return the suture wire to a straightpath as the suture wire exits fixed jaw portion 96. Furthermore, andlooking now at FIG. 23C, the mouth of the movable jaw portion's opening113 may be enlarged to help capture a suture wire deviating from astraight path.

[0109] Looking next at FIG. 24, it will be seen that one or more legs300 may be provided on suturing instrument 10, wherein legs 300 helpstabilize the tissue during suturing.

[0110] And looking next at FIG. 25, it will be seen that a grasper 400,comprising jaws 405 and 410, may be added to suturing instrument 10 tohelp stabilize the tissue during suturing.

[0111] If desired, the end effector 18 of suturing instrument 10 may beconstructed so as to have two movable, opposing jaws, rather than onefixed jaw and one movable jaw as described above.

[0112] Also, if desired, shaft rotation motor 60 and thumb buttons 26,28 may be configured so that depressing one button (e.g., button 26)will cause end effector 18 to rotate in one direction (e.g., clockwise),and depressing the other button (e.g., button 28) will cause endeffector 18 to rotate in the opposite direction (e.g.,counterclockwise).

[0113] Referring to FIG. 26, it will be seen that an alternativeembodiment of end effector 18′ includes a fixed first portion 500 havingtherein a channel 502 for retaining wire guide 76, and a smallerdiameter channel 504 for supporting the suture wire 58. The end effectorpassageway 107 houses the cutting bar 104.

[0114] As shown in FIGS. 27 and 28, the alternative embodiment of endeffector 18 further includes a fixed second portion 510 forming, inpart, the channel 502 and the passageway 107. The fixed second portion510 of end effector 18′ further includes an internal curved surface 512.The curved surface 512 forms in part the bottom of a recess 514 having afirst side wall 516 provided by the fixed first portion 500, a secondside wall 518 (FIG. 27) provided by the fixed second portion 510, and anopening 520 disposed in a planar distal end 522 (FIG. 28) of the endeffector 18′. The planar distal end 522 is formed by planar distal ends524 and 526 of the fixed first and second portions 500, 510,respectively.

[0115] In operation, the suture wire 58 is advanced through theinstrument as described above. In the above-described alternativeembodiment of end effector 18′, a distal portion 528 of the channel 504(FIG. 29) is curved, such that the wire 58, upon emergence from thechannel 504, drives distally in a circular fashion so as to enter, forexample, tissue T and thereafter turn proximally to pass through tissueT′. The circular motion may be stopped at any time to form a partialcircle of wire, as shown in FIG. 33, and, alternatively, may be repeatedonce more, or multiple times more, until the wire-driving means isstopped. The curved surface 512 serves to receive the wire 58 anddeflect the wire back toward the tissue in a circular mode.

[0116] The tissue T, T′ need not be edge-to-edge, and in manycircumstances will be layered one upon the other (FIGS. 30-32). In FIG.30 there is illustrated diagrammatically how a suture loop may beestablished by passing the suture wire 58 through both layers of tissueT, T′ and then back through the layers T′, T. The suture wire 58 may bedischarged from the instrument 10 in increments of selected length toprovide discrete individual loops, or selected numbers of loops, or“stitches”. Free ends 530 of the loop, or loops, may be twistedtogether. In FIG. 31, there is shown a similar loop of suture wire 58,but in this instance the wire 58 has been passed through tissue layer Tand looped inside tissue layer T′ and back through layer T andappropriately cut to leave the two exposed ends 530 for twistingtogether. In FIG. 32, a single loop has been placed similarly to thatshown in FIG. 31, but cut such that the free ends thereof 530 remainspaced from each other, to provide essentially an “inverted fastener”,the free ends of which are on a side of the combined layers T, T′ facingthe user. A tool 532 (FIG. 33) may be brought to bear on the suture wirefree ends 530 to complete formation of the fastener.

[0117] The diameter of the suture wire loops generated depends upon thetensile strength, or hardness, of the wire, the diameter of wire, thecurvature of the wire as it ejects from the instrument, the materialbeing penetrated, the curvature of the distal path 528, and the angle A(FIG. 29) of the distal end 522 of the end effector 18′. Suture wire forthe formation of such fasteners preferably is provided with a diameterof about 0.010 inch, though wire of a diameter of about 0.003-0.015 inchhas been found useful in particular applications.

[0118] Referring to FIG. 34, it will be seen that the looped wire 58 maybe disposed in an artery 540 and serve as a stent 542.

[0119] The instrument 10 may further be used to eject wire 58 so as totack onto a tissue, or the like, for moving and holding the tissue in aposition removed from a surgical site. Alternatively, a wire fastenedadjacent a deep surgical site may be used as a guide wire for theinsertion of other instruments.

[0120] In FIG. 35 there is shown a portion of an alternative endeffector 18″ wherein the fixed first portion 500 is provided with thechannel 502 for the wire guide 76, and the smaller channel 504 for thesuture wire. The passageway 107 for the cutting bar 104 is provided, asin the embodiment shown in FIG. 26. In the embodiment shown in FIG. 35,the cutting bar 104 carries a flexible blade 550 slidably disposed in ablade channel 552 which intersects the suture wire channel 504. The wirechannel 504 is configured to provide a pronounced looping, or coiling,of the wire as the wire ejects from the instrument 10. The fixed portion500 of the instrument is provided with a curved surface 512 which actsas a defector, directing the force of the driven suture wire andsupporting the wire which is very thin and flexible.

[0121] In use, when it is desired to cut the suture wire after ejectionof a desired length of wire, the operator manipulates the wire cuttingactuator 24 to drive the cutting bar 104, and thereby the blade 550,distally, causing the blade 550 to cut through the wire at theintersection of the suture wire channel 504 and the blade channel 552.

[0122] As noted above, one of the parameters determining the diameter ofthe suture loops is the curvature of the wire as it ejects from theinstrument. In the embodiment shown in FIG. 35, a pronounced curvaturehas been selected. It will be apparent that such curvature is a matterof choice in view of the task at hand. Another parameter determining thediameter of the suture loops is the angle A of the distal end 522 of theeffector 18″. In a modified embodiment (not shown) of the embodiments ofFIGS. 28 and 35, the end effector 18′, 18″ may be pivotally mounted onthe instrument so as to accommodate selected angular positioning of theplanar distal end 522 relative to the axis of the instrument.

[0123] In FIG. 36 there is shown another alternative embodiment of endeffector 18′″ in which the cutting bar 104′ is rotatable, rather thanmovable axially. In this embodiment, the suture wire advances throughthe channel 504 and through a notch 554 toward the operational site.Upon manipulation of the wire cutting actuator 24, the cutting bar 104′rotates, causing an edge portion 556 of notch 554 to slice through thesuture wire 58.

[0124] Referring to FIG. 37, it will be seen that in another alternativeembodiment of instrument 10, the shaft 16 may comprise first and secondshaft portions 16 a, 16 b, pivotally connected to each other, such thatthe end effector 18 can be angulated as needed to access difficult toreach areas and/or to provide an optimum angle of approach.

[0125] As is shown in FIG. 38, the end effector side walls 516, 518 andplanar distal portions 524, 526 may be interrupted by scalloped surfaces560, 562 for directing a suture coil, funnel-like, into the recess 514.Thus, a suture wire which might otherwise strike a planar surface 524,526, probably will engage one of the scalloped surfaces 560, 562, and bedirected thereby into engagement with the curved surface 512 of therecess 514.

[0126] Referring to FIGS. 39-41, it will be seen that in anotheralternative embodiment of end effector 18, the planar distal portions524, 526 are provided with rounded cut-outs 570, 572. When the planardistal surfaces 524, 526 are pressed against soft, pliable tissue, thetissue typically bulges into the cut-outs 570, 572 and thereby into therecess 514, permitting the suture wire exiting the wire channel 504 toenter the tissue well beneath the surface of the tissue, that is,penetrating more deeply into the tissue. In this embodiment, the cuttingbar 104′ is movable axially from the position shown in FIG. 39 to theposition shown in FIG. 40 to effect cutting of the suture wire proximatethe exit of the wire channel 504.

[0127] As shown in FIG. 41, the cutting bar 104′ may be provided at itsdistal end with a curved surface 574 matching in configuration thecurved surface 512 of the recess 514. Thus, when the cutting bar 104′ isin its retracted position, the cutting bar surface 574 provides acontinuation of the recess curved surface 512 and thereby contributes toguiding the suture wire into a coiled condition.

[0128] In addition to performing a cutting operation, the cutting bar104′, when axially movable, may also serve the function of tool 532shown, in FIG. 33, that is, to press the suture wire 58 into a desiredconfiguration, such as bending the wire free ends into the tissue,again, shown in FIG. 33. A combination of rotative and axial movement ofthe cutting bar 104′ can be used to effect wire forming operations afterthe wire cutting operation.

[0129] While the suture wire 58 may be round in cross section, as istypical, it is recognized that other wire cross-sectional configurationslend themselves to coiling. Accordingly, the suture wire may be providedwith an oval or polygonal cross section.

[0130] In FIGS. 42a-42 c, there is shown in operation a still furtherembodiment of end effector in which there is disposed a wire tip formingdie 580 proximate the distal portion 528 of the suture wire channel 504.When the cutting bar 104 is moved distally to cut the wire 58, thecutting bar pushes the cut end 530 of the wire into the die 580 (FIG.42b) to bend the wire cut end radially inwardly. Even after elasticrecoil of the looped wire, the cut end 530 remains directed inwardly ofthe loop, so as not to snag or tear surrounding tissue or adjacentorgans.

[0131] In FIG. 43 there is shown an alternative embodiment in which thedie 580 is disposed proximally of the distal portion 528 of the wirechannel 504. The cutting bar 104 moves proximally to effect cutting ofthe suture wire 58 and then retracts further, carrying the cut end 530of the wire 58 proximally on a cutting bar leg 582 into engagement withthe die 580. The die 580 bends the wire cut end 530 inwardly of theformed loop. The cutting bar 104 then moves distally sufficiently torelease the wire portion in the die, such that the end effector 18 maybe removed from the suture wire 58.

Modifications

[0132] It will be appreciated by those skilled in the art that numerousmodifications and variations may be made to the above-disclosedembodiments without departing from the spirit and scope of the presentinvention.

What is claimed is:
 1. A tool for joining a first layer of material to asecond layer of material, said tool comprising: a handle; an endeffector mounted on said handle and defining therein: a first channelfor retaining a wire guide; a second channel extending from the firstchannel for supporting a suture wire extending from the wire guide; apassageway for retaining a cutter bar; and an end recess; said secondchannel being curved to impart a looping configuration to portions ofthe suture wire passed therethrough; and said end recess having a curvedsurface at a bottom of said end recess, such that the end recess isadapted to receive the looped suture wire emerged from said secondchannel; a wire advancing actuator mounted on said handle for moving thesuture wire through said second channel and through the material firstand second layers; and a wire cutting actuator mounted on said handlefor moving the cutting bar into cutting engagement with the suture wire.2. The tool in accordance with claim 1 wherein said end effector isprovided with a planar distal end.
 3. The tool in accordance with claim1 wherein said cutting bar includes a flexible blade portion, and saidend effector is provided with a blade channel in which the flexibleblade is disposed and which intersects said second channel.
 4. The toolin accordance with claim 1 wherein said end effector is pivotablymounted relative to at least a portion of said handle.
 5. The tool inaccordance with claim 1 wherein said wire cutting actuator is adapted tomove the cutting bar axially into the cutting engagement with the suturewire.
 6. The tool in accordance with claim 1 wherein said wire cuttingactuator is adapted to move the cutting bar rotatively around a centralaxis thereof into the cutting engagement with the suture wire.
 7. Thetool in accordance with claim 2 wherein said end recess is provided witha funnel-like side surface defining an opening in the planar distal endfor receiving the looped suture wire and directing the received suturewire toward the recess curved bottom surface.
 8. The tool in accordancewith claim 5 wherein said end effector is provided with a planar distalend having a recessed cut-out therein, such that pressing of the distalend against a soft material layer causes bulging of the material layerinto the cut-out, to permit deep penetration of the suture wire.
 9. Thetool in accordance with claim 5 wherein a distal end of the cutting baris of a concave configuration.
 10. The tool in accordance with claim 1wherein said end effector further comprises a tip forming die proximatea distal portion of said second channel, said die and the cutting barbeing engageable with each other, after the cutting bar effects acutting operation, to bend a cut end of the suture wire inwardly of aformed loop of the suture wire.
 11. The tool in accordance with claim 1wherein the first and second layers of material comprise first andsecond layers of tissue.
 12. The tool in accordance with claim 1 whereinthe first layer of material comprises a pros thesis and the second layerof material comprises a layer of tissue.
 13. The tool in accordance withclaim 12 wherein the prosthesis comprises a surgical mesh and the layerof tissue comprises an abdominal wall.
 14. A tool for joining a firstlayer of material to a second layer of material, said tool comprising: ahandle; an end effector mounted on said handle and comprising: a firstfixed portion defining therein a first groove defining a portion of afirst channel for retaining a wire guide; a second channel extendingfrom the first channel for supporting a suture wire extending from thewire guide; a portion of a passageway for retaining a cutting bar; andwall structure defining a portion of an end recess in a distal end ofsaid end effector; and a second fixed portion defining therein a firstgroove defining a remainder of the first channel; a second groovedefining a remainder of said passageway; a wall portion defining aremainder of said second channel; and a sidewall for defining aremainder of the end recess; said second channel being curved to imparta looping configuration to portions of the suture wire passedtherethrough; the end recess being defined in part by a curved surfacein said end effector defining a bottom of the end recess, such that theend recess is adapted to receive the looped suture wire emerged fromsaid second channel; a wire advancing actuator mounted on said handlefor moving the suture wire through said second channel and through thematerial first and second layers; and a wire cutting actuator mounted onsaid handle for moving the cutting bar into cutting engagement with thesuture wire.
 15. The tool in accordance with claim 14 wherein said firstand second fixed portions are provided with first and second planardistal ends, respectively, and the first and second planar distal endsare in the same plane.
 16. The tool in accordance with claim 14 whereinsaid cutting bar includes a flexible blade portion and said first fixedportion is provided with a blade channel in which the flexible blade isdisposed and which intersects with second channel.
 17. The tool inaccordance with claim 14 wherein said end effector is pivotally mountedrelative to at least a portion of said handle.
 18. The tool inaccordance with claim 14 wherein said wire cutting actuator is adaptedto move the cutting bar axially into the cutting engagement with thesuture wire.
 19. The tool in accordance with claim 14 wherein said wirecutting actuator is adapted to move the cutting bar rotatively around acentral axis thereof into the cutting engagement with the suture wire.20. The tool in accordance with claim 15 wherein said end recess isprovided with a funnel-like side surface defining an opening in theplanar distal end for receiving the looped suture wire and directing thereceived suture wire toward the recess curved bottom surface.
 21. Thetool in accordance with claim 18 wherein said end effector is providedwith a planar distal end having a recessed cut-out therein, such thatpressing of the distal end against a soft material layer causes bulgingof the material layer into the cut-out, to permit deep penetration ofthe suture wire.
 22. The tool in accordance with claim 18 wherein adistal end of the cutting bar is of a concave configuration.
 23. Thetool in accordance with claim 14 wherein said first fixed portionfurther comprises a tip forming die proximate a distal portion of saidsecond channel, said die and the cutter bar being engageable with eachother, after the cutting bar effects a cutting operation, to bend a cutend of the suture wire inwardly of a formed loop of the suture wire. 24.The tool in accordance with claim 14 wherein the first and second layersof material comprise first and second layers of tissue.
 25. The tool inaccordance with claim 14 wherein the first layer of material comprises aprosthesis and the second layer of material comprises a layer of tissue.26. The tool in accordance with claim 25 wherein the prosthesiscomprises a surgical mesh and the layer of tissue comprises an abdominalwall.